Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Participants were enrolled in a total of 30 sites in the United States. The first participant was screened on 30 March 2009.

Last participant visit:

Primary endpoint analysis (Week 24): November 2009

Week 48 analysis: April 2010

Week 96 analysis: March 2011

End of study: September 2013

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

126 participants were screened; 71 were randomized (48 to the Stribild group and 23 to the Atripla group). All randomized participants received at least 1 dose of study medication and comprised the safety and intent-to-treat (ITT) analysis sets. No site enrolled more than 7% of participants.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Safety Analysis Set: participants were randomized and received at least 1 dose of study medication.

Reporting Groups

Description

Stribild

Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.

Atripla

Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or